United States - English - NLM (National Library of Medicine)

biomarin pharmaceutical inc. - cerliponase alfa (unii: x8r2d92qp1) (cerliponase alfa - unii:x8r2d92qp1) - cerliponase alfa 150 mg in 5 ml - brineura is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (cln2), also known as tripeptidyl peptidase 1 (tpp1) deficiency. brineura is contraindicated in patients with: - any sign or symptom of acute, unresolved localized infection on or around the device insertion site (e.g. cellulitis or abscess); or suspected or confirmed cns infection (e.g. cloudy csf or positive csf gram stain, or meningitis) [see warnings and precautions (5.1)] . - any acute intraventricular access device-related complication (e.g., leakage, extravasation of fluid, or device failure) [see warnings and precautions (5.2)] . - ventriculoperitoneal shunts. risk summary there are no available data on brineura use in pregnant women to inform a drug-associated risk of pregnancy-related outcomes. animal reproduction studies have not been conducted using cerliponase alfa. the estimated background risk of major birth defects and miscarr

Australia - English - Department of Health (Therapeutic Goods Administration)

biomarin pharmaceutical australia pty ltd - cerliponase alfa, quantity: 30 mg/ml - injection, solution - excipient ingredients: dibasic sodium phosphate heptahydrate; sodium chloride; potassium chloride; magnesium chloride hexahydrate; calcium chloride dihydrate; water for injections; monobasic sodium phosphate monohydrate - brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (cln2) disease, also known as tripeptidyl peptidase 1 (tpp1) deficiency.

Israel - English - Ministry of Health

medison pharma ltd - cerliponase alfa - solution for infusion - cerliponase alfa 30 mg / 1 ml - cerliponase alfa - brineura is indicated for the treatment of patients with neuronal ceroid lipofuscinosis type 2 (cln2) disease, also known as tripeptidyl peptidase 1 (tpp1) deficiency.

European Union - English - EMA (European Medicines Agency)

biomarin international limited - cerliponase alfa - neuronal ceroid-lipofuscinoses - other alimentary tract and metabolism products, - brineura is indicated for the treatment of neuronal ceroid lipofuscinosis type 2 (cln2) disease, also known as tripeptidyl peptidase 1 (tpp1) deficiency,

Canada - English - Health Canada

biomarin international limited - cerliponase alfa - solution - 150mg - cerliponase alfa 150mg - enzymes

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

biomarin europe ltd - cerliponase alfa - solution for infusion - 30mg/1ml

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - fluticasone propionate - suspension - fluticasone propionate 400 mcg/actuation - fluticasone - fluticasone - flixonase nasule drops are indicated for the regular treatment of nasal polyps and associated symptoms of nasal obstruction.

New Zealand - English - Medsafe (Medicines Safety Authority)

haleon new zealand ulc - fluticasone propionate 0.05%{relative};   - nasal spray suspension - 0.05% w/w - active: fluticasone propionate 0.05%{relative}   excipient: benzalkonium chloride dispersible cellulose glucose hydrochloric acid phenethyl alcohol polysorbate 80 purified water - flixonase allergy & hayfever 24 hour is indicated for the prophylaxis and treatment of allergic rhinitis including hay fever and that caused by other airborne allergens such as house dust mite, mould spores and animal dander. during treatment flixonase allergy & hayfever 24 hour provides symptomatic relief of sneezing, itchy and runny nose, congestion including associated sinus discomfort and pressure around the nose and eyes. flixonase allergy & hayfever 24 hour also provides relief of ocular symptoms associated with allergic rhinitis.

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - fluticasone propionate, quantity: 400 microgram - nasal drops - excipient ingredients: polysorbate 20; sorbitan monolaurate; monobasic sodium phosphate; dibasic sodium phosphate; sodium chloride; water for injections - indications: for the treatment of mild to moderate nasal polyps and associated symptoms of nasal obstruction in adults and adolescents over 16 years of age.

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - fluticasone propionate - suspension - fluticasone propionate 0.05 g / 100 g - fluticasone - fluticasone - self medication:prophylaxis and treatment of seasonal allergic rhinitis including hay fever in adults.by physicians order:prophylaxis and treatment of seasonal allergic rhinitis including hay fever in children of the age of 4 years and above and perennial rhinitis in adults and children of the age of 4 years and above.